Job Number: 21-13379
Job Number: 21-13379
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Document Specialist for our client in Phoenix, AZ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- The QA Doc Control Specialist administers elements of the site Document Change Control process which include reviewing, approving, reporting on, and monitoring GMP documents in the document management system.
- Uses manual and electronic document management tools and systems to perform document change control duties.
- Under general supervision, develops Standard Operating Procedures (SOPs) and forms for areas of expertise within the QA Document Control group.
- Works and interacts with other departments on a routine basis.
- Performs and monitors all documents activities in compliance with SOPs, cGMPs and regulatory requirements.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
- The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
- There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
- Employees holding this position will be required to perform any other job-related duties as requested by management.
- Ability to properly communicate e-mails and routine business matters with management with high level of accuracy.
- Intermediate computer skills to increase department's productivity, including basic scientific knowledge.
- Basic writing skills and ability to follow technical reports.
- Must be action-oriented and customer-focused and possess learning agility.
- Ability to learn from mistakes and actively listen
- Basic MS Word, Outlook, Excel
- Ability to deal appropriately with regulatory agencies
- Basic knowledge of cGMP, OSHA, DEA, USP and EP
- Requires flexibility and ability to multi-task
- Requires strong written and verbal communication skills
- Ability to interpret / write general business documents
- Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, and tolerance
- Ability to solve routine problems
- Perform routine documentation related activities.
- Processes and implements GMP Document revisions; prepares document drafts and final masters per approved document change controls; reviews document change packages submitted to assure all required documents are complete and present; initiates workflow routings as needed, schedules and implements approved changes; notifies appropriate personnel of new, revised and obsolete documentation.
- Reviews all quality-related documentation for adherence to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) compliance, accuracy and completeness
- Manages/coordinates controlled document periodic review process.
- Assists end user in creation of documents and formatting as requested.
- Creates, maintains and/or verifies learning management system records associated with implemented controlled documentation.
- Revises or creates documentation relating to subject matter.
- Schedules and performs required department audits.
- Perform activities and tasks related to QA Document Control Center.
- Maintains QA Document Control Center.
- Coordinates and maintains controlled documentation received from other departments or from outside the site; administers and monitors site approval process as needed.
- Coordinates and issues manufacturing batch records; Issue batch documentation to production as needed and per production schedule; Participates in scheduling and planning meetings with production and packaging, as assigned.
- Performs second verification as required.
- Perform non-routine activities to support site and department needs.
- Performs special projects as assigned.
- Conducts training on department subjects.
- Supports internal and external audits as needed.
- Perform other duties as assigned.
- Bachelor's degree preferred.
- 3 years' relevant work experience required, preferably in Quality Assurance and/or Quality Control in a regulated setting.
- An equivalent combination of education, experience and training may substitute.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.